More Choices at Last

For more than two decades, contraceptive innovations have been at a virtual standstill, leaving American women dissatisfied with what they considered imperfect choices.

But a flurry of new contraceptives is finally arriving. The products--some already on the market and others still in development--are more convenient and, in some cases, as effective as sterilization (99%) at preventing pregnancy.

Two new hormonal contraceptives--a monthly shot and a new type of IUD--were designed to appeal to women who find birth control pills inconvenient. Women have long complained that it’s hard to remember to swallow a pill at the same time each day, especially if they travel a lot.

New mechanical methods were developed to improve upon the cervical cap and diaphragm for women who can’t or don’t want to take hormones.

There is no single reason for the anticipated birth control bonanza. A marketplace long dominated by a few big companies has attracted smaller firms that see untapped potential to reach specific groups of women. They recognize that among women who don’t like their contraceptive, compliance is poor. With half of all pregnancies in this country unplanned, it’s not that the contraceptives are failing; it’s that women fail to use them consistently and properly.

Another reason U.S. women will have expanded choice is that federal spending on barrier contraceptive research, which began in the mid-1990s, has begun to pay off. As a result, alternatives to the diaphragm and cervical cap are getting closer to FDA approval, although the researchers still haven’t perfected spermicides effective against both pregnancy and sexually transmitted diseases.

That the new products are coming to fruition at the same time “is a matter of sheer chance,” says James Trussell, a Princeton University economist who studies contraceptives. “You could call it a banner year for new methods,” said Dr. Robert Rebar, former chairman of the ob-gyn department at the University of Cincinnati.

The two newest offerings, the Lunelle monthly shot and Mirena IUD, have been on the market for a few months. Anita Miyake, a married mother of three, is typical of their intended customer.

“I’m not one to remember to take the pill everyday,” said Miyake, who participated in a research study of Lunelle at Harbor-UCLA Medical Center in Torrance. “I liked it. It’s a nice method. It’s convenient.”

In November, she began using the Mirena IUD, which can be left in place five years: “It’s wonderful,” said Miyake, 31, who does outreach work in women’s health at Harbor-UCLA. “I know I’m protected all the time and my periods are a lot lighter.”

Many U.S. women are similarly eager to try reliable new methods.

“Women have clearly demonstrated they are amenable to looking at new methods of contraception other than oral contraceptives,” said Rebar, now associate executive director of the American Society for Reproductive Medicine in Birmingham, Ala. They are especially receptive, he said, to hormonal methods that deliver more of the drug locally and less into the bloodstream.

Two promising hormonal alternatives awaiting marketing approval by the Food and Drug Administration also should appeal to women looking for reliable, longer-acting contraception that doesn’t interfere with sexual spontaneity. They are a patch that delivers hormones through the skin and a plastic ring that releases hormones inside the vagina for 21 days.

Most of the new contraceptives have been in development 10 to 15 years, some tweaking technologies already in use. Hormone replacement patches, for example, were adapted to deliver contraceptives, and the maker of a three-month synthetic progesterone injection came up with the one-month estrogen and progesterone injection that restores fertility sooner after a woman stops it.

The U.S. contraceptive landscape has always been idiosyncratic. Unlike in other countries, the top choice of American women 18 to 45 is sterilization, followed by the birth control pill, a 1960 innovation that at today’s lower doses has fewer side effects.

Part of the reliance on sterilization is driven by the limits of insurance and the way in which litigation has tainted methods popular overseas, such as the IUD.

“Contraceptive coverage almost always includes coverage for surgical sterilization of a woman but often has not covered other options,” said Dr. Felicia Stewart, an ob-gyn with UC San Francisco’s Center for Reproductive Health Research and Policy. “In the past, women have been financially biased toward having surgery. You might lose your coverage next week, so once your tubes are tied, you don’t have to pay for anything anymore.”

It remains unclear which of the new contraceptives will be covered by health insurers, which have been expanding coverage of contraceptives. Some insurers may be unlikely to cover the $350 to $395 upfront cost for a Mirena IUD, plus insertion fees, thinking a woman is unlikely to remain enrolled long enough for the plan to realize the benefit.

“The system is not set up to foster thinking about contraceptive cost-effectiveness,” said Trussell. “By and large, women pay for their own contraceptives, but insurance companies pay for the pregnancies.”

Although the IUD offers years of cost-effective protection, it’s not popular in the United States. Manufacturers and women have been put off by the taint of the Dalkon Shield, an IUD taken off the U.S. market in 1974 after design flaws led to infections, sterility and some deaths.

Complications removing Norplant--six small matchstick-sized rods, each containing progesterone and inserted under the skin of the upper arm--dampened U.S. enthusiasm for implants. But that’s about to be challenged with Implanon, from Organon Inc. It consists of a single plastic rod that’s easier to insert and to remove.

What’s nice about the new methods, say doctors, is that they recognize a woman’s needs change through her reproductive years.

“We used to think about this whole field as if we were all middle-aged, all comfortably married people who had sex two to three times a week,” Stewart said. “It’s certainly not the way we live and the way young people are.”

For example, younger women not yet in stable relationships, or teenage girls who may not have access to a health professional, are more likely to rely on nonprescription products at the pharmacy.

An obvious example of how consumers’ desires drive the current market is Allendale Pharmaceuticals’ effort to revive the Today sponge, a popular method that won raves from many women, despite its modest 89% to 91% effectiveness. When its previous maker pulled it from the market, women’s frustrations were highlighted in a memorable episode from the “Seinfeld” TV show in which the character Elaine seeks to buy every remaining Today sponge and evaluates potential romantic partners on the basis of whether they are “spongeworthy.” Allendale Chief Executive Gene Detroyer is hopeful Today could be approved for U.S. marketing by October.

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Here are some brief summaries of the new and emerging contraceptive methods:

HORMONAL METHODS (interfere with the release of an egg or with sperm getting to the egg):

Lunelle: A monthly injection of synthetic estrogen and progesterone into the arm, buttocks or hip that allows women to “only make one decision a month,” said Dr. Anita Nelson, medical director of the women’s health care program at Harbor-UCLA Medical Center. The drug costs $25 to $30 a month, comparable to birth control pills, plus a fee for administering it. Lunelle can be given anywhere from day 23 to day 33 of a woman’s cycle.

While the few women who have tried it so far have not balked at the inconvenience of a monthly trip to the doctor, Pharmacia Corp., which makes Lunelle, is studying two more convenient alternatives: allowing pharmacists to administer the shot, and developing a different version of the drug that a woman could inject herself.

Mirena IUD: This device, from Berlex Laboratories, has been on the U.S. market since late January. The device, which is designed for five years of use but could last seven, is coated with a potent form of the reproductive hormone progesterone, called levonorgestrel, just a little of which is released each day. This hormonal IUD thickens the mucus of the cervix, preventing sperm from getting through. It is said to be about 99% effective in preventing pregnancy.

NuvaRing: A thin, flexible plastic ring about 2 inches across; contains a combination of estrogen and progestin and is inserted into the vagina. The manufacturer, Organon Inc., said it is hopeful of getting FDA approval this summer. The ring stays in the vagina for 21 days, then is left out for seven days so that a woman can have her period. It releases lower doses of estrogen than the low-dose birth control pills on the market, which means it has fewer side effects.

Implanon: A single-implant version of the Norplant implant using desogestrel, which Nelson called “a kinder, gentler progesterone” than what’s found in Norplant. Its maker, Organon Inc., which already sells the product overseas, expects to apply for FDA approval in 2002. Because it’s a single implant that comes with a special inserter, it’s easier to place than previous implants, and its stiffer plastic material makes it less likely to break during removal. Unlike Norplant, which lasts five years, it lasts for three, a more practical interval for women seeking reversible contraception between the births of their children.

Ortho Evra: A seven-day patch that provides steady doses of estrogen and progestin. A woman places the first patch on her lower abdomen or buttocks, wears it for a week and then replaces it with new patches during the second and third weeks of her cycle. During the fourth week, she removes the patch and has her period. A unit of Johnson & Johnson is seeking approval from the FDA.

New birth control pills: Organon Inc. received FDA approval in December for Cyclessa, the lowest-dose triphasic pill, which offers different levels of hormones, more closely mimicking the body’s natural hormone levels throughout the 21 days a woman takes it. Organon expects to roll it out this year. Barr Laboratories’ Seasonale, a three-month continuous birth control pill regimen consisting of 84 days on the hormones and a week off for a period, is still in testing, which will continue into early 2002. It’s expected to reach the market in mid-2003 and will be priced comparably to other monthly pills.

BARRIER DEVICES (block the cervix so sperm cannot get through):

FemCap: A silicone rubber cervical cap developed by Dr. Alfred Shihata, a family doctor in Del Mar, Calif., that comes in three sizes, based on how much a woman’s cervix has been enlarged by pregnancy and delivery. Already in use in Europe, it has not yet been approved in this country. Unlike other caps, for which a woman applies a spermicide inside the dome of the cap, the surface that touches the cervix, this cap has a special groove that allows spermicide or microbicide, which is potentially irritating, to be placed on the outside of the cap, without touching the cervix.

Unlike other caps, which fit over the cervix only, it also features a brim that forms a seal against the vaginal walls to make sure sperm and any spermicides aren’t getting to the cervix. It allows multiple acts of intercourse and can be removed by pulling on a strap.

Lea Shield: A diaphragm-like barrier, available in a single size, with a unique one-way valve allowing vaginal fluids to escape, but blocking sperm from entering the cervix. The FDA is studying the device, which is already in use in Canada.

Another new contraceptive device is a spermicidal translucent film that is folded and inserted into the vagina. The Ortho Options Vaginal Contraceptive Film contains more of the spermicide nonoxynol-9 than a similar film on the market, says the manufacturer.

Doctors hope the new products will motivate doctors and health officials to provide more information to women about their contraceptive options. More than half the young women in this country have their first intercourse without contraception.

“Any time you introduce a new thing, people perk up. It reminds them to think about the whole topic,” Stewart said. “We get a little bump in attention.”